Tuesday, 26 March 2019

Questions (801)

Clare Daly

Question:

801. Deputy Clare Daly asked the Minister for Health the number of suspected adverse reactions to the HPV vaccine reported to the Health Products Regulatory Authority, HPRA, as at 31 December 2018; the number of cases reported; the number of system organ class reactions reported; the percentage of cases categorised as serious; the number of cases unresolved; and the regular intervals the HPRA is required to update its national monitoring webpage. [13524/19]

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Written answers (Question to Health)

From the time of first authorisation of Gardasil in 2006 and up to 31/12/2018, the Health Products Regulatory Authority (HPRA) had received 1,187 reports/cases of suspected adverse reactions and events associated with the use of the HPV vaccines (Gardasil, Cervarix and a few reports for which the brand of vaccine is not known).  These reports include information on some 5,616 reactions, as many reports/cases contain information on more than one reaction/event, so as you will note, the number of reactions exceeds the number of reports/cases.

In accordance with EU and global reporting requirements, the words used to describe suspected adverse reactions/events are coded by the HPRA to an internationally agreed standard terminology (MedDRA), which is used to facilitate exchange of information by organisations responsible for medicines monitoring.  Within this terminology, reaction terms are grouped into System Organ Classes’ (SOCs) by etiology (e.g. Infections and infestations), manifestation site (e.g. Gastrointestinal disorders) or purpose (e.g. Surgical and medical procedures).  The 5,616 reactions referred to above occurred across a broad range of SOCs, most frequently involving the general disorders and administration site conditions, gastrointestinal disorders, nervous system disorders, psychiatric disorders and skin/subcutaneous tissue disorders.

Of the 1,187 reports/cases of suspected adverse reactions and events associated with the use of the HPV vaccines (Gardasil, Cervarix and a few reports for which the brand of vaccine hasn’t been identified), 60% are classified as ‘serious’ as per the regulatory definition of a ‘serious’ adverse reaction, which includes circumstances where patients require intervention (e.g. review by their GP) and/or treatment for their symptoms.  From currently available information, in 319 reports/cases, the patients were described as ‘not recovered at time of reporting’ and the outcome in a further 167 reports/cases was recorded as ‘unknown’.  It is important to note that the HPRA receives reports/cases from a variety of sources and at the time of submission and/or follow up, information on the outcome of the effects experienced may not be available to reporters.

I am informed by the HPRA that it updates its website in relation to report/case figures for HPV vaccine periodically, approximately bi-annually with the last update covering the period to 31/12/18.